Endodontically Treated TeethTRNNCT05289973
Effect of TruNatomy and HyFlex EDM Instrumentation on Postoperative Pain
A study testing TruNatomy Files and HyFlex EDM Files in people with Endodontically Treated Teeth, run by Cairo University.
Trial summary
The aim of the present study is to clinically compare the incidence of postoperative pain after root canal preparation using TruNatomy system and HyFlex Electrical Discharge Machined (EDM) rotary system in asymptomatic necrotic mandibular molars. Read more about this study
- Who is it for?
- Ages 25 to 45 years
- Conditions the study is for
- Endodontically Treated Teeth
- What is being tested?
- TruNatomy Files and HyFlex EDM Files
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2022to 1 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 25 - 45 years old.
- Males or Females.
- Mandibular molar teeth with:
- No pain.
- No response to pulp testing.
- Radiographic appearance with or without a periapical radiolucency.
Who cannot join
- Patients with pre-operative pain.
- Patients having significant systemic disorders.
- Patients who are allergic to non-steroidal anti-inflammatory drugs.
- Patients with two or more adjacent teeth requiring root canal therapy.
- Teeth that have:
- Vital pulp tissues.
Show all 12Show fewer
- Association with swelling or fistulous tract.
- Acute or chronic peri-apical abscess.
- Greater than grade I mobility.
- Pocket depth greater than 5mm.
- No possible restorability.
- Previous endodontic treatment.
Trial locations and contacts
No sites are listed yet.
Angie Ghoneim, PHD contact
About this study
Official title: Effect of TruNatomy and HyFlex EDM Instrumentation on Postoperative Pain in Asymptomatic Necrotic Molars.
The aim of the present study is to clinically compare the incidence of postoperative pain after root canal preparation using TruNatomy system and HyFlex Electrical Discharge Machined (EDM) rotary system in asymptomatic necrotic mandibular molars.
Read the detailed description
Up till now, there are no clinical studies on the effect of instrumentation using TruNatomy files on post-operative pain. Furthermore, these newly introduced files can provide more affordable means for instrumentation. Therefore, the purpose of this study is to clinically compare the effect of using TruNatomy files and HyFlex EDM files on post-operative pain.
- Conditions
- Endodontically Treated Teeth
- Being tested
- TruNatomy Files, HyFlex EDM Files
- Medical subject headings
- Tooth, Nonvital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TruNatomy FilesDevice
Newly introduced endodontic file with high flexibility.
HyFlex EDM FilesDevice
Endodontic files
| Study group | Role | What they receive |
|---|---|---|
| TruNatomy Files | Experimental | Newly introduced endodontic file Receives: Device: TruNatomy Files |
| Hyflex EDM | Experimental | Endodontic file Receives: Device: HyFlex EDM Files |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative pain : measure pain level change from zero(no pain) pain Post-operative pain Post-operative pain
The pain will be recorded according to the modified visual analogue scale. The scale consists of a line marked from 1 to 10 where 10 represent the most intense pain imaginable and the worst outcome.
Measured: Post-operative pain measured 6, 12, 24, 48, 72 hours and 7 days post-operatively.
Secondary outcomes (1)
Number of analgesics taken by the patient after endodontic treatment
Counting Number of analgesics taken by the patient after endodontic treatment
Measured: up to 7 days post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study start1 Aug 2022 (estimated)
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Endodontically Treated TeethStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- patients having mandibular molars with necrotic pulp
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nora El-Sayed Khater, Cairo University
- Investigators
- Angie Ghoneim, PHD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05289973
- Sponsor's protocol ID
- TRN in postoperative pain
- Acronym
- TRN
- Status last verified
- Jul 2022
- First submitted
- 22 Dec 2021
- Last updated
- 19 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Thompson SA. An overview of nickel-titanium alloys used in dentistry. Int Endod J. 2000 Jul;33(4):297-310. doi: 10.1046/j.1365-2591.2000.00339.x.
PubMed 11307203Arias A, de la Macorra JC, Hidalgo JJ, Azabal M. Predictive models of pain following root canal treatment: a prospective clinical study. Int Endod J. 2013 Aug;46(8):784-93. doi: 10.1111/iej.12059. Epub 2013 Feb 12.
PubMed 23402273Ruiz-Hubard EE, Gutmann JL, Wagner MJ. A quantitative assessment of canal debris forced periapically during root canal instrumentation using two different techniques. J Endod. 1987 Dec;13(12):554-8. doi: 10.1016/S0099-2399(87)80004-3. No abstract available.
PubMed 3482231
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of TruNatomy and HyFlex EDM Instrumentation on Postoperative Pain in Asymptomatic Necrotic Molars.
- ClinicalTrials.gov ID
- NCT05289973
- Acronym / sponsor ID
- TRN / TRN in postoperative pain
- Conditions
- Endodontically Treated Teeth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (estimated)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Feb 2023 (estimated)
- First posted
- 22 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the present study is to clinically compare the incidence of postoperative pain after root canal preparation using TruNatomy system and HyFlex Electrical Discharge Machined (EDM) rotary system in asymptomatic necrotic mandibular molars.
Detailed description
Up till now, there are no clinical studies on the effect of instrumentation using TruNatomy files on post-operative pain. Furthermore, these newly introduced files can provide more affordable means for instrumentation. Therefore, the purpose of this study is to clinically compare the effect of using TruNatomy files and HyFlex EDM files on post-operative pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- patients having mandibular molars with necrotic pulp
| Arm | Type | Receives |
|---|---|---|
| TruNatomy Files | Experimental | Device: TruNatomy FilesNewly introduced endodontic file |
| Hyflex EDM | Experimental | Device: HyFlex EDM FilesEndodontic file |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age between 25 - 45 years old.
- Males or Females.
- Mandibular molar teeth with:
Key exclusion criteria (12 listed)
- Patients with pre-operative pain.
- Patients having significant systemic disorders.
- Patients who are allergic to non-steroidal anti-inflammatory drugs.
- Patients with two or more adjacent teeth requiring root canal therapy.
- Teeth that have:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TruNatomy FilesNewly introduced endodontic file with high flexibility. | Device | TruNatomy Files |
| HyFlex EDM FilesEndodontic files | Device | Hyflex EDM |
Primary outcome
Post-operative pain : measure pain level change from zero(no pain) pain Post-operative pain Post-operative pain
Time frame: Post-operative pain measured 6, 12, 24, 48, 72 hours and 7 days post-operatively.
The pain will be recorded according to the modified visual analogue scale. The scale consists of a line marked from 1 to 10 where 10 represent the most intense pain imaginable and the worst outcome.
1 secondary outcome
Number of analgesics taken by the patient after endodontic treatment
Time frame: up to 7 days post-operatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
- Background: PubMed 11307203Thompson SA. An overview of nickel-titanium alloys used in dentistry. Int Endod J. 2000 Jul;33(4):297-310. doi: 10.1046/j.1365-2591.2000.00339.x.
- Background: PubMed 23402273Arias A, de la Macorra JC, Hidalgo JJ, Azabal M. Predictive models of pain following root canal treatment: a prospective clinical study. Int Endod J. 2013 Aug;46(8):784-93. doi: 10.1111/iej.12059. Epub 2013 Feb 12.
- Background: PubMed 3482231Ruiz-Hubard EE, Gutmann JL, Wagner MJ. A quantitative assessment of canal debris forced periapically during root canal instrumentation using two different techniques. J Endod. 1987 Dec;13(12):554-8. doi: 10.1016/S0099-2399(87)80004-3. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angie Ghoneim, PHD contact
Angie Ghoneim, PHD study director
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing TruNatomy Files and HyFlex EDM Files in people with Endodontically Treated Teeth, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nora El Khater, B.D.S (02-01063918844, nora.khater@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative pain : measure pain level change from zero(no pain) pain Post-operative pain Post-operative pain (time frame: Post-operative pain measured 6, 12, 24, 48, 72 hours and 7 days post-operatively.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05289973, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2022.